Handbook

Clinical trials are an essential step in the development of a new therapeutic product. This course is designed to provide students with the skills to implement and manage clinical trials, including obtaining ethics approval. Clinical Data Interchange Standards Consortium (CDISC), electronic data capture and CONSORT will be discussed along with the creation, use, validation and security of electronic databases. Finally, the students will discuss the future of clinical trials in the development of new therapeutics and the global requirements for the conduct of clinical trials.